Question 1

Brazilian device classification rules are similar to those of ______________.

Options :

A : Japan

B : USFDA

C : EU

D : China

Answer: C

Question 2

According to EU MDR 2017/745, what is the meaning of the requirement to reduce risks ‘as far as possible’?

Options :

A : The reduction of risks as far as possible without considering the benefit-risk ratio

B : The reduction of risks as far as possible even with adversely affecting the benefit-risk ratio

C : The reduction of risks as far as possible without adversely affecting the benefit-risk ratio

D : The reduction of risks as far as possible without considering regulatory compliance risk

Answer: C

Question 3

Which of the following is useful to graphically summarize and display the relative importance of the differences between groups of data?

Options :

A : Flowchart

B : Cause and effect diagram

C : Pareto chart

D : Scatter diagram

Answer: C

Question 4

What can be the best suitable ‘severity’ rating to measure the possible consequences of hazard if the hazard can result in ‘patient death’? NOTE: Rating scale from highest to lowest: catastrophic, critical, serious, minor & negligible.

Options :

A : Serious

B : Minor

C : Catastrophic

D : Negligible

Answer: C

Question 5

If validation study was not conducted on resterilization, what is true?

Options :

A : The device can be resterilized and the same is recorded in Design master record

B : The device can be resterilized and the same is recorded in Device history record (DHR)

C : The device cannot be resterilized

D : The device can be resterilized and the same is recorded on product label

Answer: C